This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions.   The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the...
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The FDA release a final guidance, “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on October 30, 2017. This supersedes “New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff” dated February 19, 1998. This guidance defines the process for De Novo submissions for devices with no...
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FDA CDRH maintains a webpage for De Novo Summaries: Evaluation of Automatic Class III Designation De Novo Summaries. This is for devices that are novel but low to moderate risk ((not ideal for 510(k)s and PMA would be overly burdensome). There are now two options for de novo classification. One is in response to an...
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